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510(k) K121533

ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET by Tosoh Bioscience, Inc. — Product Code LPS

K121533 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET". The FDA issued a decision of Substantially Equivalent on June 15, 2012. The device falls under product code LPS (Urinary Homocystine (Nonquantitative) Test System), a Class II device regulated under 21 CFR 862.1377. Tosoh Bioscience, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2012
Date Received
May 24, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinary Homocystine (Nonquantitative) Test System
Device Class
Class II
Regulation Number
862.1377
Review Panel
CH
Submission Type

Other clearances by Tosoh Bioscience, Inc.

  • K250073 — Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 (October 3, 2025)
  • K211199 — ST AIA-PACK BNP Assay (November 8, 2021)
  • K200904 — Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 (August 5, 2021)
  • K160113 — ST AIA-PACK hsE2 Calibrator Set (February 17, 2016)
  • K153417 — ST AIA-PACK PROG III Calibrator Set (December 18, 2015)
  • K150270 — ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PAC (October 26, 2015)
  • K143075 — ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator Set (July 2, 2015)
  • K143296 — AIA-PACK C-Peptide Control Set (December 16, 2014)
  • K143144 — ST AIA-PACK PROG II Calibrator Set (December 3, 2014)
  • K140648 — ST AIA-PACK C-PEPTIDE II CALIBRATOR SET (April 10, 2014)

Other clearances for product code LPS

  • K123930 — VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VE (May 15, 2013)
  • K121053 — DIAZYME HOMOCYSTEINE POC TEST KIT (July 31, 2012)
  • K113793 — HOMOCYSTEINE TEST (June 5, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K083222 — AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 (July 31, 2009)
  • K080851 — A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY (October 10, 2008)
  • K073640 — ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS (April 24, 2008)
  • K071971 — DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZ (September 17, 2007)
  • K063701 — TECO HOMOCYSTEINE ENZYMATIC ASSAY (April 11, 2007)
  • K063206 — DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CON (December 28, 2006)

FDA data resources